Background: Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of cancer-related deaths in the United States. Screening can prevent CRC by detecting advanced precancerous lesions. Adherence to screening is crucial in reducing CRC disease burden; however, there is limited research on the impact of digital outreach screening uptake and adherence. Objective: This study evaluated the impact of different digital outreach channels on patient adherence to CRC screening with a multi-target stool DNA (mt-sDNA) test in a real-world setting. Methods: Patients were individuals aged 45 to 85 years with a valid mt-sDNA test order from Exact Sciences Laboratories, LLC (Jan. 1, 2023-Sept. 23, 2023). All patients received letters and phone calls; some received short message service (SMS), email, or both. Adherence and time to test return were compared across digital outreach categories stratified by patient characteristics. Multivariable regression evaluated the association of digital outreach methods with adherence and time to test return. Results: Among 2 425 308 patients (43.5% between 50 and 64 years, 58.2% female), digital SMS only (62.7%) was the most common outreach method. Overall adherence was 70.1%, with highest adherence in the digital SMS-plus-email group (72.9%). Mean time to test return from shipment of mt-sDNA kit to receipt of valid test was 25.8 days. In adjusted analyses, patients receiving digital SMS plus email had the highest odds of test return (odds ratio, 1.75; 95% confidence interval [CI], 1.73-1.78; P<.001) and had return times 8.7% shorter than the no-digital-outreach group (95% CI, 8.2-9.2; P<.001). Discussion: Among nationally insured individuals within the recommended age range for CRC screening, overall adherence to the mt-sDNA test was in the 70s, with the highest rates in the digital (SMS and email) outreach group and the lowest in the no-digital-outreach group. Conclusions: These findings highlight the importance of multichannel navigation in facilitating completion of CRC screening with the mt-sDNA test.

In the United States (US), (CRC) is the second leading cause of cancer death in the Hispanic population overall. Unfortunately, the CRC screening rate in Hispanics is significantly lower than in White adults. The current study utilized real-world data to examine adherence to CRC screening with the mt-sDNA test in the Hispanic population. Additionally, sociodemographic factors that might influence patient adherence were examined to identify potential adherence barriers.

This study linked two data sources: Komodo Research Data + MapEnhance Komodo Lab database and the Exact Sciences Laboratories database. Participants were Hispanic individuals aged 45-75 years who were new users of mt-sDNA testing between 2016 and 2023. Logistic regression was used to identify factors associated with adherence to mt-sDNA testing.

In the overall study population (n = 807,611), adherence to mt-sDNA testing was 64.3%. Significant variation in adherence was observed by payer type: Medicaid (53.3%), Managed Care Organization (53.4%), Medicare Advantage (62.3%), Medicare (66.5%), and commercial (66.7%) (p < 0.0001). Logistic regression identified additional factors that were significantly associated with greater adherence: older age, coverage by commercial insurance, residing outside metropolitan areas, prescription for CRC screening from a gastrointestinal doctor, and receiving digital outreach.

In this large, national study of combined laboratory and claims data, Hispanic individuals in the US demonstrated an overall adherence rate of 64.3%. Adherence was particularly influenced by older age, testing that was ordered by a GI specialist, and digital outreach. These data support mt-sDNA testing as a promising strategy to improve CRC screening participation among Hispanic individuals.

Colorectal cancer (CRC) poses significant mortality risks, particularly among Black individuals, who experience the highest CRC incidence and mortality rates in the United States. This study examined adherence to multi-target stool DNA (mt-sDNA) testing in this population.

This retrospective cohort analysis used Exact Sciences Laboratories (ESL)-linked claims data from January 2017 to December 2023 on Black patients in the United States aged 45 and older. High-risk individuals, those with payers other than commercial plans, managed care organizations, Medicare Advantage, Medicaid, or Medicare, and individuals with mt-sDNA prescriptions outside the study period were excluded. Adherence was defined as the percentage of patients returning the test kit with valid results within 365 days of shipment. Logistic regression analysis was used to identify factors associated with adherence.

Among 434,951 patients included in the study, the overall adherence to mt-sDNA testing was 62.0% (N = 266,981), with a mean time to adherence of 27.6 days (SD = 44.17). Females, older adults (76+ years), and non-metropolitan residents had higher adherence than males, younger adults, and metropolitan patients (all p < 0.001), respectively. Patients with orders from GI specialists had higher adherence than other prescribing clinicians (NP/PA: OR = 0.39, OB/GYN: OR = 0.54, Other: OR = 0.38, PCP: OR = 0.50; all p < 0.001). Digital outreach, especially SMS and email combination, was also associated with higher adherence (OR = 1.25, p < 0.001).

This large, national study found a 62.0% adherence rate to mt-sDNA testing among Black individuals. Higher adherence was associated with being female, older age, non-metropolitan residence, and digital outreach. While the findings highlight the promise of mt-sDNA, further research is needed to explore its full potential in improving CRC screening adherence across different demographic groups.

Adherence to colorectal cancer (CRC) re-screening is essential to maximize screening effectiveness. This study assessed adherence to a multi-target stool DNA (mt-sDNA) test among previous users in the USA across different payer types.

Data from Exact Sciences Laboratories LLC (01/01/2023-12/31/2023) were used. Insured patients (45-85 years) who were shipped an mt-sDNA test during the data coverage period and had previously completed mt-sDNA screening with a negative result ≥ 2.5 years prior were included. Mt-sDNA re-screening adherence rate and mean time to test return were compared across payer types, and their associations with patient characteristics were assessed using multivariable regression models.

Of 793,567 patients (50-75 years: 89.0%; female: 62.0%), the re-screening adherence rate was 84.0% (from 66.5% for Medicaid to 90.2% for Medicare); mean (standard deviation) time to test return was 20.7 (20.8) days (from 19.2 [19.7] for Medicare to 22.4 [22.2] for Medicaid). Characteristics associated with higher likelihood of re-screening adherence included older ages (odds ratio [OR] = 1.25 and 1.11 for 65-75 and 76-85 years, respectively, relative to 45-49 years), living in a ZIP code with higher median household income (OR = 1.80 for > $200,000 relative to < $50,000), full digital outreach (OR = 1.84 relative to no digital outreach), and ≥ 3rd rounds of screening (OR = 2.44 relative to 2nd round of screening).

Adherence to CRC re-screening with mt-sDNA test was high across payer types, with sustained adherence in later rounds of screening. Strategies to improve re-screening rates in subgroups associated with lower re-screening adherence are warranted.

Colorectal cancer (CRC) screening is underutilized among those with lower socioeconomic status and in racial and ethnic minoritized populations who have been disproportionately impacted by COVID.

To compare disparities in CRC screening before and after the onset of the COVID pandemic among privately insured individuals.

Retrospective cohort study using deidentified claims data from the USA between January 1, 2017, and December 31, 2022.

Blue Cross Blue Shield beneficiaries aged 50-75 years with average risk of CRC.

Mean screening use was compared by demographic and area-level socioeconomic factors between the periods preceding (January 1, 2017 to February 28, 2020) and following (July 1, 2020 to December 31, 2022) the onset of the COVID pandemic. Difference-in-differences analysis was used to evaluate changes in screening differences.

Our study included 21,724,223 beneficiaries. Compared to males, females had higher screening in both periods (p < 0.05), and this sex difference in screening increased 1.63% (95% confidence interval [CI]: 1.32%, 1.94%) following the onset of the pandemic. Compared to residents in areas with high socioeconomic status (SES), low SES area residents had lower screening (p < 0.001) during both periods. Furthermore, this difference grew 4.32% (95% CI, 3.76%, 4.88%) during the post-onset period. Metropolitan area residents had higher screening than non-metropolitan area residents during both periods (p < 0.001); however, this difference decreased 0.77% (95% CI, 0.34%, 1.20%) during the post-onset period. Among beneficiaries with high risk of CRC, the difference in screening based on social deprivation index and metropolitan area status increased 6.99% (95% CI, 5.77%, 8.20%) and 1.82% (95% CI, 0.88%, 2.74%), respectively.

Among privately insured individuals, CRC screening after the COVID pandemic recovered unevenly based on sex, area-level socioeconomic measures, and metropolitan area status, with pre-pandemic disparities persisting and even worsening for some of the factors.

Colorectal cancer (CRC) is the second leading cause of cancer mortality in the USA and is highly preventable, with early screening vital for improving outcomes. This study aimed to evaluate adherence rates of multi-target stool DNA (mt-sDNA) testing, following updated guidelines recommending screening starting at age 45.

This retrospective cohort study used aggregated data from Exact Sciences Laboratories LLC, examining new users (first-time testers) aged 45-85 with commercial, Medicare, or Medicaid insurance who received mt-sDNA test kits (point-of-care) between January 1, 2023, and June 1, 2023. Adherence was defined as the percentage of eligible participants returning a valid non-empty test kit within 365 days of initial shipment date. Descriptive statistics and logistic regression were used to analyze adherence.

Among 1,557,915 patients, the overall adherence rate to mt-sDNA testing was 71.3% (commercial insurance 72.3%, Medicare Advantage 70.2%, Medicare 69.9%, Medicaid 52.0%) (p < 0.001). Females had slightly higher adherence than males, except for commercial insurance (72.2% vs. 72.6%, p < 0.001). Adherence was highest in commercial insurance for individuals aged 76-85 (79.2%, p < 0.001), gastroenterology patients (82.5%, p < 0.001), and rural residents (73.2%, p < 0.001), along with those in Medicare Advantage earning $200 K + (78.5%, p < 0.001).

Adherence to mt-sDNA testing was robust, particularly among individuals with commercial insurance, older adults, gastroenterology patients, higher income groups, and rural residents. With a 71% adherence rate, the test demonstrates substantial engagement and value in colorectal cancer screening. Future research should assess its long-term impact and address disparities to optimize its benefits.

Introduction: Asian Americans have lower colorectal cancer (CRC) screening rates compared to other racial/ethnic groups. Given the importance of early detection and subsequent treatment in improving survival, this study examines adherence to first-time multitarget stool DNA (mt-sDNA) testing among Asian American patients.Methods: This retrospective study linked two data sources: Komodo Research Data + MapEnhance Komodo Lab database and the Exact Sciences Laboratories database. Asian American's 45 years and older who were first-time users of mt-sDNA testing between 2017 and 2023, with continuous insurance enrollment for two years, were included. Adherence to mt-sDNA testing was analyzed using descriptive statistics and logistic regression to identify factors associated with adherence.Results: The final sample included 336 288 Asian American patients, primarily covered by commercial insurance (70.3%), aged 50-75 years (80.7%), female (56.5%), living in metropolitan areas (95.4%), and under the care of a primary care physician (74.9%). Overall adherence to mt-sDNA testing was 70.9%, with significant variation by payer type ranging from 60.7% for Medicaid to 72.2% for Medicare (P < 0.0001). Overall adherence rates were approximately 70% across all age groups, sexes, and geographic regions but were notably high among gastroenterology (GI) provider patients (81.6%) and those receiving full digital outreach (via both SMS and email) (72.8%). Logistic regression identified several significant predictors of adherence: older age, males, coverage by commercial insurance, residing outside metropolitan areas, seeing GI providers, receiving digital outreach via SMS or both SMS and email, and preferring English.Conclusion: This study found that Asian American patients that were first-time users of mt-sDNA testing had high adherence rates. However, significant disparities existed within this population based on payer type and sociodemographic factors. Targeted outreach strategies are essential to reduce barriers and improve CRC screening uptake, ultimately reducing the burden of CRC in the Asian American population.

Few studies have evaluated multitarget stool DNA (mt-sDNA) in clinical practice. We analyzed mt-sDNA utilization at the University of Pittsburgh Medical Center.

We assessed mt-sDNA orders between January 1, 2017, and December 31, 2021. Data collection included electronic capture of mt-sDNA orders, completed stool submissions, and test results. Multivariable models were used to assess associations between mt-sDNA completion and results and age, sex, and race.

There were 91,664 mt-sDNA orders in 73,704 patients. A total of 54.7% (40,337/73,704) completed an mt-sDNA test, and 7,424 (18.6%) tested positive. Completion rates increased by age <50-59 years (N = 12,818; 48.2%), 60-69 years (14,982; 56.3%), and ≥70 years (N = 9,850; 55.6%) ( P < 0.0001). The completion rate for males (52.7%; 15,297/29,025) did not differ significantly from females (53.3%; 22,353/41,901) ( P = 0.09). By race, the completion rates of White patients (54.1%; 34,874/64,512) and Asian patients (56.9%; 493/867) were higher than those of Black patients (38.8%; 1,699/4,376) ( P < 0.0001). Test completion declined with repeat mt-sDNA orders, with ≤32% completion rate after ≥3 orders. In a multivariable model, older age was associated with greater likelihood of a positive test (odds ratio 1.22, 95% confidence interval 1.20-1.24, P < 0.0001), and Black patients had lower odds of a positive test (odds ratio 0.65, 95% confidence interval 0.56-0.76, P < 0.0001).

Only 54.7% of patients completed their mt-sDNA test order. Older individuals were more likely to complete testing and test positive. Black patients were less likely to complete testing and, unexpectedly, less likely to test positive. Further exploration of mt-sDNA utilization including better understanding of the determinants of uptake, appropriateness, and evaluation of outcomes at colonoscopy is needed.

The feasibility of population screening for colorectal cancer has been demonstrated in several studies. Most of these studies have considered individual characteristics, diagnostic approaches, epidemiological data, and socioeconomic factors. In this article, we comment on an editorial by Metaxas et al published in the recent issue of the journal. The authors emphasized the need to raise public awareness through health education programs and the possibility of using easily accessible non-invasive screening methods. Here, we focus on non-invasive molecular genetic approaches that can aid in colorectal cancer screening. On the one hand, we highlighted the use of tumor DNA/RNA markers directly for screening and, on the other hand, underline the use of polygenic risk assessment and hereditary predisposition to select individuals for more thorough cancer screening.

The multi-target stool DNA (mt-sDNA) test screens for colorectal cancer by analyzing DNA methylation/mutation and hemoglobin markers to algorithmically derive a qualitative result. A new panel of highly discriminant candidate methylated DNA markers (MDM) was recently developed. Performance of the novel MDM panel, with hemoglobin, was evaluated in a simulated screening population using archived stool samples weighted to early-stage colorectal cancer and prospectively collected advanced precancerous lesions (APL). Marker selection study (MSS) and separate preliminary independent verification studies (VS) were conducted utilizing samples from multi-center, case-control studies. Sample processing included targeted MDM capture, bisulfite conversion, and MDM quantitation. Fecal hemoglobin was quantified using ELISA. Samples were stratified into 75%/25% training-testing sets; model outcomes were cross-validated 1,000 times. All laboratory operators were blinded. The MSS included 232 cases (120 colorectal cancer/112 APLs) and 490 controls. The VS featured 210 cases (112 colorectal cancer/98 APLs) and 567 controls; APLs were 86.7% adenomas and 13.3% sessile serrated lesions (SSL). Average age was 65.5 (cases) and 63.2 (controls) years. Mean sensitivity in the VS from cross-validation was 95.2% for colorectal cancer and 57.2% for APLs, with specificities of 89.8% (no CRC/APLs) and 92.4% (no neoplasia). Subgroup analyses showed colorectal cancer sensitivities of 93.4% (stage I) and 94.2% (stage II). APL sensitivity was 82.9% for high-grade dysplasia, 73.4% for villous lesions, 49.8% for tubular lesions, and 30.2% for SSLs. These data support high sensitivity and specificity for a next-generation mt-sDNA test panel. Further evaluation of assay performance will be characterized in a prospective, multi-center clinical validation study (NCT04144738).

This study highlights performance of the next-generation mt-sDNA test, which exhibits high sensitivity and specificity for detecting colorectal cancer and APLs. This noninvasive option has potential to increase screening participation and clinical outcomes. A multi-center, clinical validation trial is underway. See related commentary by Bresalier, p. 93.

This analysis estimated the outcomes of triennial blood-based colorectal cancer (CRC) screening at various adherence, including perfect adherence, compared with triennial multi-target stool DNA (mt-sDNA) screening at the reported real-world adherence rate.

The validated CRC-AIM model simulated a US cohort of average-risk individuals receiving triennial screening with mt-sDNA or blood-based test from ages 45 to 75 years. Modeled specificity and sensitivity were based on reported data. Adherence was set at a real-world rate of 65.6% for mt-sDNA and at 65.6%, relative 10% incremental increases from 65.6%, or 100% for the blood-based test. Costs of mt-sDNA and the blood-based test were based on prices for clinically available tests ($508.87 and $895, respectively). Value-based pricing was estimated at a willingness-to-pay threshold of $100,000.

Both tests resulted in life-years gained (LYG), reduced CRC cases, and reduced deaths versus no screening. With adherence for mt-sDNA set at 65.6% and for blood-based test set at 100%, mt-sDNA resulted in 30% more LYG, 52% more averted CRC cases, and 32% more averted CRC deaths. At reported sensitivity and specificity rates, mt-sDNA at 65.6% adherence dominates (is more effective and less costly) the blood-based test at any adherence. There was no price at which triennial screening with the blood-based test at any adherence was cost-effective compared with mt-sDNA at 65.6% adherence.

Triennial screening with mt-sDNA resulted in better clinical outcomes at a lower cost compared with the modeled blood-based test even at perfect adherence, supporting application of blood-based tests only as a secondary screening option.

Insufficient adherence to colorectal cancer (CRC) screening impedes individual and population health benefits, with about one-third of individuals non-adherent to available screening options. The impact of poor adherence is inadequately considered in most health economics models, limiting the evaluation of real-world population-level screening outcomes. This study introduces the CAN-SCREEN (Colorectal cANcer SCReening Economics and adherENce) model, utilizing real-world adherence scenarios to assess the effectiveness of a blood-based test (BBT) compared to existing strategies.

The CAN-SCREEN model evaluates various CRC screening strategies per 1,000 screened individuals for ages 45-75. Adherence is modeled in two ways: (1) full adherence and (2) longitudinally declining adherence. BBT performance is based on recent pivotal trial data while existing strategies are informed using literature. The full adherence model is calibrated using previously published Cancer Intervention and Surveillance Modeling Network (CISNET) models. Outcomes, including life-years gained (LYG), CRC cases averted, CRC deaths averted, and colonoscopies, are compared to no screening.

Longitudinal adherence modeling reveals differences in the relative ordering of health outcomes and resource utilization, as measured by the number of colonoscopies performed per 1,000, between screening modalities. BBT outperforms the fecal immunochemical test (FIT) and the multitarget stool DNA (mtsDNA) test with more CRC deaths averted (13) compared to FIT and mtsDNA (7, 11), more CRC cases averted (27 vs. 16, 22) and higher LYG (214 vs. 157, 199). BBT yields fewer CRC deaths averted compared to colonoscopy (13, 15) but requires fewer colonoscopies (1,053 vs. 1,928).

Due to limited data, the CAN-SCREEN model with longitudinal adherence leverages evidence-informed assumptions for the natural history and real-world longitudinal adherence to screening.

The CAN-SCREEN model demonstrates that amongst non-invasive CRC screening strategies, those with higher adherence yield more favorable health outcomes as measured by CRC deaths averted, CRC cases averted, and LYG.

To describe member adherence to a mail-based, health insurer-sponsored gap closure program for colorectal cancer (CRC) screening using multi-target stool DNA (mt-sDNA; Cologuard®) tests.

Combined patient data from Exact Sciences Laboratories LLC and data from mass-mailed mt-sDNA orders placed by a large Medicare Advantage Insurance Plan were analyzed (03/01/2023-06/30/2023). Adherence and time to test return were the primary and secondary outcomes, respectively. Their association with patient characteristics was evaluated using multivariable regression.

Among the 3201 member-patients included (86.6% aged 65-75 years; 58.7% female), adherence rate was 49.4%, and mean time to test return was 25.5 days. After multivariable adjustment, the odds of test return were significantly higher among 65- to 75-year-olds (odds ratio [OR] = 1.59 relative to 45- to 64-year-olds), those living in small towns (OR = 1.43 relative to metropolitan-located individuals), and with digital outreach via both SMS and email (OR = 4.31 relative to no digital outreach). Time to test return was shorter in 65- to 75-year-olds than in 45- to 64-year-olds and was not associated with other patient characteristics.

Mass-mailed mt-sDNA tests for CRC screening were associated with an overall adherence rate of about 50% in this Medicare Advantage population, with higher likelihood of test return among patients receiving digital outreach.

Despite clear evidence that regular screening reduces colorectal cancer (CRC) mortality and the availability of multiple effective screening options, CRC screening continues to be underutilized in the US. A systematic literature search of four databases - Ovid, Medline, EBSCHOhost, and Web of Science - was conducted to identify US studies published after 2017 that reported on barriers and facilitators to CRC screening adherence. Articles were extracted to categorize relevant CRC screening barriers or facilitators that were assessed against CRC screening outcomes using the 5As dimensions: Access, Affordability, Acceptance, Awareness, Activation. Sixty-one studies were included. Fifty determinants of screening within the 5As framework and two additional dimensions including Sociodemographics and Health Status were identified. The Sociodemographics, Access, and Affordability dimensions had the greatest number of studies included. The most common factor in the Access dimension was contact with healthcare systems, within the Affordability dimension was insurance, within the Awareness dimension was knowledge CRC screening, within the Acceptance dimension was health beliefs, within the Activation dimension was prompts and reminders, within the Sociodemographics dimension was race/ethnicity, and among the Health Status dimension was chronic disease history. Among all studies, contact with healthcare systems, insurance, race/ethnicity, age, and education were the most common factors identified. CRC screening barriers and facilitators were identified across individual, clinical, and sociocontextual levels. Interventions that consider multilevel strategies will most effectively increase CRC screening adherence.

The Centers for Medicare & Medicaid Services (CMS) recommend covering blood-based tests meeting proposed minimum performance thresholds for colorectal cancer (CRC) screening. Outcomes were compared between currently available stool-based screening tests and a hypothetical blood-based test meeting CMS minimum thresholds. Using the Colorectal Cancer and Adenoma Incidence and Mortality Microsimulation Model (CRC-AIM), outcomes were simulated for average-risk individuals screened between ages 45 and 75 years with triennial multitarget stool DNA (mt-sDNA), annual fecal immunochemical test (FIT), and annual fecal occult blood test (FOBT). Per CMS guidance, blood-based CRC screening was modeled triennially, with 74% CRC sensitivity and 90% specificity. Although not specified by CMS, adenoma sensitivity was set between 10% and 20%. Published adenoma and CRC sensitivity and specificity were used for stool-based tests. Adherence was set at (1) 100%, (2) 30%-70%, in 10% increments, and (3) real-world rates for stool-based tests (mt-sDNA = 65.6%; FIT = 42.6%; FOBT = 34.4%). Assuming perfect adherence, a blood-based test produced ≥19 lower life-years gained (LYG) than stool-based strategies. At the best-case scenario for blood-based tests (100% adherence and 20% adenoma sensitivity), mt-sDNA at real-world adherence achieved more LYG (287.2 vs. 297.1, respectively) with 14% fewer colonoscopies. At 100% blood-based test adherence and real-world mt-sDNA and FIT adherence, the blood-based test would require advanced adenoma sensitivity of 30% to reach the LYG of mt-sDNA (297.1) and ∼15% sensitivity to reach the LYG of FIT (258.9). This model suggests that blood-based tests with CMS minimally acceptable CRC sensitivity and low advanced adenoma sensitivity will frequently yield inferior outcomes to stool-based testing across a wide range of adherence assumptions.

The United States Preventive Services Taskforce (USPSTF) recently recommended lowering the age for average-risk colorectal cancer (CRC) screening from 50 to 45 years. While initiating screening at age 45 versus 50 provides a greater opportunity for CRC early detection and prevention, the full profile of benefits, risks, and cost-effectiveness of expanding the screen-eligible population requires further evaluation.

The costs and clinical outcomes for screening at age 45 for triennial multi-target stool DNA [mt-sDNA], and other non-invasive stool-based modalities (annual fecal immunochemical test [FIT] and annual fecal-occult blood test [FOBT]), were estimated using the validated CRC-AIM microsimulation model over a lifetime horizon. Test sensitivity and specificity inputs were based on 2021 USPSTF modeling analyses; adherence rates were based on published real-world data and the costs of the screening test, follow-up colonoscopies, complications, and CRC care were included. Outcomes are reported from the perspective of a United States payer as clinical, life-years gained (LYG), and incremental cost-effectiveness ratio (ICER); stool-based and follow-up colonoscopy adherence ranges were explored in one-way, probabilistic and threshold analyses.

When compared to initiation of CRC screening at age 45 versus 50, all modalities reduced both the incidence of and mortality from CRC and increased LYG. Initiating CRC screening at age 45 was cost-effective with an ICER of $59,816 and $35,857 per quality-adjusted life year (QALY) for mt-sDNA versus FIT and FOBT, respectively. In the threshold analyses, at equivalent rates to stool-based screening, mt-sDNA was always cost-effective at a willingness-to-pay threshold of $100,000 per QALY versus FIT and FOBT.

Initiating average-risk CRC screening at age 45 instead of age 50 increases the estimated clinical benefit by reducing disease burden while remaining cost-effective. Among stool-based screening modalities, mt-sDNA provides the most clinical benefit in a Commercial and Medicare population.

Our study aimed to identify pathways from the source of information to the uptake of cancer genetic testing, with consideration of intermediate variables including perceptional, attitudinal and psychosocial factors. We used the Health Information National Trends Survey (2020 database) and constructed a structural equation model for pathway analysis (using SPSS version 24). Variables for socio-demographic, lifestyle and health information were also collected and used for confounding adjustment. A total of 2941 participants were analyzed (68.5%, non-Hispanic white; 59.7%, females; 58 years, median age; and 142 (4.8%) had undertaken genetic testing for cancer risk previously). Our pathway analysis found that only information from particular sources (i.e., healthcare providers and genetic counsellors) had positive and significant effects on people’s perceptions of cancer regarding its prevention, detection and treatment (standardized β range, 0.15−0.31, all p-values < 0.01). Following the paths, these perceptional variables (cancer prevention, detection and treatment) showed considerable positive impacts on the uptake of genetic testing (standardized β (95% CIs): 0.25 (0.20, 0.30), 0.28 (0.23, 0.33) and 0.12 (0.06, 0.17), respectively). Pathways involving attitudinal and psychosocial factors showed much smaller or insignificant effects on the uptake of genetic testing. Our study brings several novel perspectives to the behavior model and may underpin certain issues regarding cancer risk genetic testing.

Commercial insurance covers a follow-up colonoscopy after a positive colorectal cancer-screening test with no patient cost-sharing. Instituting a similar policy for Medicare beneficiaries may increase screening adherence and improve outcomes. The cost-effectiveness of stool-based colorectal cancer screening was compared across adherence scenarios that assumed Medicare coinsurance status quo (20% for follow-up colonoscopy) or waived coinsurance. The CRC-AIM model simulated previously unscreened eligible Medicare beneficiaries undergoing stool-based colorectal cancer screening at age 65 for 10 years. Medicare costs, colorectal cancer cases, colorectal cancer-related deaths, life-years gained (LYG), and quality-adjusted life-years (QALY) were estimated versus no screening. Scenario 1 (S1) assumed 20% coinsurance for follow-up colonoscopy. Scenario 2 (S2) assumed waived coinsurance without adherence changes. Scenarios 3-7 (S3-S7) assumed that waiving coinsurance increased real-world stool-based screening and/or follow-up colonoscopy adherence by 5% or 10%. Sensitivity analyses assumed 1%-4% increased adherence. Cost-effectiveness threshold was ≤$100,000/QALY. Waiving coinsurance without adherence changes (S2) did not affect outcomes versus S1. S3-S7 versus S1 over 10 years estimated up to 3.6 fewer colorectal cancer cases/1,000 individuals, up to 2.1 fewer colorectal cancer deaths, up to 20.7 more LYG, and had comparable total costs per-patient (≤$6,478 vs. $6,449, respectively) as reduced colorectal cancer medical costs offset increased screening and colonoscopy costs. In sensitivity analyses, any increase in adherence after waiving coinsurance was cost-effective and increased LYG. In simulated Medicare beneficiaries, waiving coinsurance for follow-up colonoscopy after a positive stool-based test improved outcomes and was cost-effective when assumed to modestly increase colorectal cancer screening and/or follow-up colonoscopy adherence.

Follow-up colonoscopy after a positive stool-based test is necessary to complete the colorectal cancer-screening process. This analysis demonstrated that in a simulated Medicare population, waiving coinsurance for a follow-up colonoscopy improved estimated outcomes and was cost-effective when it was assumed that waiving the coinsurance modestly increased screening adherence. See related Spotlight, p. 641.

The multitarget stool DNA test with fecal immunochemical test (sDNA-FIT) is recommended by all major US guidelines as an option for colorectal cancer screening. It is approved by the Food and Drug Administration for use in average-risk individuals aged 45 years and older. The sDNA-FIT tests for 11 biomarkers, including point mutations in KRAS, aberrant methylation in NDRG4 and BMP3, and human hemoglobin. Patients collect a stool sample at home, send it to the manufacturer's laboratory within 1 day, and the result is reported in approximately 2 weeks. Compared with FIT, sDNA-FIT has higher sensitivity but lower specificity for colorectal cancer, which translates to a higher false-positive rate. A unique feature of sDNA-FIT is the manufacturer's comprehensive patient navigation system, which operates 24 hours a day and provides active outreach for patient education and reminders in the first month after a test is ordered. Retesting is recommended every 1-3 years, although the optimal testing interval has not yet been determined empirically. The cost of sDNA-FIT is $681 without insurance, but Medicare and most private insurers cover it with no copay or deductible.

Cancer screening is an important way to reduce the burden of cancer. The COVID-19 pandemic created delays in screening with the potential to increase cancer disparities in the United States (U.S.). Data from the 2014-2020 Behavioral Risk Factor Surveillance System (BRFSS) survey were analyzed to estimate the percentages of adults who reported cancer screening in the last 12 months consistent with the U.S. Preventive Services Task Force (USPSTF) recommendation for cervical (ages 21-65), breast (ages 50-74), and colorectal cancer (ages 50-75) prior to the pandemic. Cancer screening percentages for 2020 (April-December excluding January-March) were compared to screening percentages for 2014-2019 to begin to look at the impact of the COVID-19 pandemic. Screening percentages for 2020 were decreased from those for 2014-2019 including several underserved racial groups. Decreases in mammography and colonoscopy or sigmoidoscopy were higher among American Indian/Alaskan Natives, Hispanics, and multiracial participants, but decreases in pap test were also highest among Hispanics, Whites, Asians, and African-Americans/Blacks. Decreases in mammograms among women ages 40-49 were also seen. As the 2020 comparison is conservative, the 2021 decreases in cancer screening are expected to be much greater and are likely to increase cancer disparities substantially.